U.S. patent application number 12/479395 was filed with the patent office on 2010-12-09 for methods and devices for accessing a body cavity using a surgical access device with modular seal components.
This patent application is currently assigned to ETHICON ENDO-SURGERY, INC.. Invention is credited to Michael D. Cronin, Michael S. Cropper, Daniel H. Duke, Denzel Z. Herrera-Davis, Christopher J. Hess, Kevin L. Houser, Gregory W. Johnson, Jeffrey D. Messerly, Kyle P. Moore, Jerome R. Morgan, Daniel J. Mumaw, Katherine J. Schmid, Frederick E. Shelton, IV, William B. Weisenburgh, II.
Application Number | 20100312063 12/479395 |
Document ID | / |
Family ID | 42651464 |
Filed Date | 2010-12-09 |
United States Patent
Application |
20100312063 |
Kind Code |
A1 |
Hess; Christopher J. ; et
al. |
December 9, 2010 |
METHODS AND DEVICES FOR ACCESSING A BODY CAVITY USING A SURGICAL
ACCESS DEVICE WITH MODULAR SEAL COMPONENTS
Abstract
Methods and devices are provided for providing access through
tissue to a surgical site. In one embodiment, a surgical access
device can include a hollow tubular member and a modular seal
member. The modular seal member can be configured to radially span
a lumen of the tubular member and can be removably and replaceably
matable to a portion of the tubular member. The access device can
also include a plurality of access ports, each of which can be
configured to mate with the modular seal member at a respective
desired location.
Inventors: |
Hess; Christopher J.;
(Cincinnati, OH) ; Moore; Kyle P.; (Mason, OH)
; Duke; Daniel H.; (West Chester, OH) ; Mumaw;
Daniel J.; (Cincinnati, OH) ; Schmid; Katherine
J.; (Cincinnati, OH) ; Cropper; Michael S.;
(Edgewood, KY) ; Messerly; Jeffrey D.;
(Cincinnati, OH) ; Weisenburgh, II; William B.;
(Maineville, OH) ; Morgan; Jerome R.; (Cincinnati,
OH) ; Cronin; Michael D.; (Cincinnati, OH) ;
Herrera-Davis; Denzel Z.; (Cincinnati, OH) ; Johnson;
Gregory W.; (Milford, OH) ; Houser; Kevin L.;
(Springdale, OH) ; Shelton, IV; Frederick E.;
(Hillsboro, OH) |
Correspondence
Address: |
Ethicon Endo-Surgery/Nutter, McClennen & Fish LLP
Seaport West, 155 Seaport Blvd.
Boston
MA
02210-2604
US
|
Assignee: |
ETHICON ENDO-SURGERY, INC.
Cincinnati
OH
|
Family ID: |
42651464 |
Appl. No.: |
12/479395 |
Filed: |
June 5, 2009 |
Current U.S.
Class: |
600/204 |
Current CPC
Class: |
A61B 2017/3466 20130101;
A61B 2017/3484 20130101; A61B 2017/3449 20130101; A61B 17/3423
20130101; A61B 2017/00287 20130101; A61B 2017/3445 20130101; A61B
17/3462 20130101; A61B 2017/3488 20130101 |
Class at
Publication: |
600/204 |
International
Class: |
A61M 29/00 20060101
A61M029/00 |
Claims
1. A surgical access device, comprising: a hollow tubular member
having proximal and distal ends and a side wall defining a lumen,
the hollow tubular member being configured to be positioned in an
opening in tissue; and a modular seal member removably and
replaceably matable to a portion of the tubular member, the seal
member being configured to radially span the lumen of the tubular
member and to receive at least one access port.
2. The device of claim 1, further comprising a flexible retractor
configured to be positioned in an opening in tissue and configured
to receive the hollow tubular member within a passageway
therethrough.
3. The device of claim 1, wherein the tubular member further
includes at least one tissue connector configured to secure a
portion of the tubular member to tissue.
4. The device of claim 1, wherein the seal member includes a
continuous puncturable membrane.
5. The device of claim 4, further comprising a plurality of access
ports, each of which is configured to mate with the puncturable
membrane at a respective desired location, each access port having
a sealing element and being configured to receive and form a seal
around an instrument inserted therethrough.
6. The device of claim 5, wherein at least one of the plurality of
access ports is configured to penetrate the puncturable
membrane.
7. The device of claim 5, wherein the access ports have different
characteristics selected from at least one of port diameter, port
length, port shape, and port stiffness.
8. The device of claim 1, wherein the modular seal member has a
plurality of mounts pre-formed therein at predetermined locations,
each mount being configured to receive an access port.
9. The device of claim 1, further comprising a plurality of
interchangeable modular seal members, each having a plurality of
mounts pre-formed therein at predetermined locations, each mount
being configured to receive an access port.
10. The device of claim 9, wherein the interchangeable modular seal
members have different characteristics selected from at least one
of location of mounts, diameter of mounts, length of mounts, shape
of mounts, and stiffness of mounts.
11. The device of claim 9, further including a plurality of access
ports matable within the mounts.
12. The device of claim 11, wherein the access ports have different
characteristics selected from port diameter, port length, port
shape, and port stiffness.
13. The device of claim 9, wherein the mounts are movable relative
to one another.
14. A surgical access kit, comprising: a hollow tubular member
having proximal and distal ends and a side wall defining a lumen,
the hollow tubular member being configured to be positioned in an
opening in tissue; at least one continuous, puncturable seal member
removably and replaceably matable with the tubular member and
configured to seal the lumen; and a plurality of access ports, each
of which is configured to mate with the puncturable membrane at a
respective desired location in a sealing engagement, each access
port having a sealing element and being configured to receive and
form a seal around an instrument inserted therethrough.
15. The surgical access kit of claim 14, wherein at least one of
the plurality of access ports is configured to penetrate the
puncturable membrane.
16. The surgical access kit of claim 14, further comprising at
least one tissue connector configured to secure a portion of the
tubular member to tissue.
17. A surgical access kit, comprising: a hollow tubular member
having proximal and distal ends and a side wall defining a lumen,
the hollow tubular member being configured to be positioned in an
opening in tissue; at least one modular seal member removably and
replaceably matable with a portion of the tubular member, the seal
member having formed therein at least one mount that is configured
to receive an access port; and a plurality of access ports, each
selectively matable within one of the mounts in a sealing
engagement.
18. The surgical access kit of claim 17, further comprising a
plurality of mounts formed in the seal member, each mount being
configured to receive one of the access ports.
19. The surgical access kit of claim 17, wherein the access ports
have different characteristics selected from port diameter, port
length, port shape, and port stiffness.
20. The surgical access kit of claim 17, further comprising at
least one tissue connector configured to secure a portion of the
tubular member to tissue.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to methods and devices for
performing surgical procedures, and in particular to methods and
devices for accessing a body cavity.
BACKGROUND OF THE INVENTION
[0002] Minimally invasive surgical techniques such as endoscopies
and laparoscopies are often preferred over traditional open
surgeries because the recovery time, pain, and surgery-related
complications are typically less with minimally invasive surgical
techniques. In many laparoscopic procedures, the abdominal cavity
is insufflated with carbon dioxide gas to a pressure of
approximately 15 mm Hg. The abdominal wall is pierced and a cannula
or trocar that is approximately 5 to 10 mm in diameter is inserted
into the abdominal cavity. Typically multiple cannulas or trocars
are inserted and placed at the surgical site so multiple
instruments, such as laparoscopic telescopes, graspers, dissectors,
scissors, retractors, etc., can be used at the same time. While
miniaturized versions of laparoscopic procedures have also been
developed, the instruments for such procedures are generally more
expensive and fragile, and still typically require the use of
multiple instruments or channels that have diameters of about 2 to
3 mm.
[0003] Because of the rise in popularity of minimally invasive
surgeries, there has been significant development with respect to
the procedures and the instruments used in such procedures. For
example, in some procedures a single incision at the navel can be
sufficient to provide access to a surgical site. This is because
the umbilicus can be a preferred way to access an abdominal cavity
in a laparoscopic procedure. The umbilical incision can be easily
enlarged without significantly compromising cosmesis and without
significantly increasing the chances of wound complications, thus
allowing multiple instruments to be introduced through a single
incision. However, a "chopstick" effect can occur which causes
interference between the surgeon's hands and the instruments. This
interference greatly reduces the surgeon's ability to perform a
desired procedure.
[0004] Some surgical access devices have been developed to try and
reduce the "chopstick effect." For example, a device can include a
chamber having a plurality of separate sealing channels that are
configured to access a surgical location. Each sealing channel can
be configured to receive an instrument and can seal the outside
environment from the surgical location. Current devices designed to
alleviate the "chopstick effect," however, have their own unique
problems. The location and size of the sealing channels can limit
use of the device to specific instruments or to a specific
procedure. If a different instrument is needed that cannot fit
within the sealing channels, the entire device may need to be
removed which can increase the length and complexity of the
procedure.
[0005] Further, because insufflation is generally used as part of
laparoscopic procedures, a resulting force is applied to the
cannula that causes the cannula to be undesirably pushed in a
direction out of a body, like a cork in a pressurized liquid
bottle. While the assemblies can generally be sutured in place, the
retention and stability capabilities of such assemblies are weak.
Additionally, because the cannula is sutured to the tissue,
removing the cannula during the course of the surgical procedure is
both difficult and inconvenient. Thus, a surgeon is typically
unable to easily remove objects from the surgical site or to use
different types of cannulas during a single procedure.
[0006] Accordingly, there is a need for improved methods and
devices for accessing a surgical site during a laparoscopic
procedure. There is additionally a need for procedures and devices
that allow access devices to be easily removed from a surgical site
and replaced during a surgical procedure.
SUMMARY OF THE INVENTION
[0007] The present invention generally provides methods and devices
for providing surgical access into a body cavity. In one exemplary
embodiment, a surgical access device is provided that includes a
hollow tubular member that is configured to be positioned in an
opening in tissue and that has proximal and distal ends and a
sidewall defining a lumen. In addition, a modular seal member that
is configured to radially span the lumen of the tubular member can
be removably and replaceably matable to a portion of the tubular
member.
[0008] The surgical access device can be positioned, secured, or
affixed within an opening in tissue in any number of ways. In some
embodiments, the hollow tubular member can include at least one
tissue connector configured to secure a portion of the tubular
member to tissue. In other embodiments, the hollow tubular member
can be received within a passageway in a flexible retractor that is
positioned in an opening in tissue.
[0009] The surgical access device and its components can have
various configurations. In one embodiment, the modular seal member
can be configured to receive at least one access port. For example,
the seal member can include a continuous puncturable membrane. The
device can also include a plurality of access ports, each of which
is configured to mate with the puncturable membrane at a respective
desired location. The access ports can have any number of
configurations, for example, each access port can have a sealing
element that is configured to receive and form a seal around an
instrument inserted therethrough. In some embodiments, the access
ports can be configured to penetrate the puncturable membrane. The
configuration of the access ports can vary in any number of ways.
For example, any one or more of the port diameter, port length,
port shape, and port stiffness can vary and each of the access
ports can have different characteristics.
[0010] In other embodiments, the modular seal member can have a
plurality of mounts pre-formed therein at predetermined locations,
each mount being configured to receive an access port. In some
embodiments, a plurality of access ports can be matable within
and/or on the mounts. The access ports mounted to the mounts can
also vary in any number of ways. For example, any one or more of
the port diameter, port length, port shape, and port stiffness or
the access ports can vary and each of the access ports can have
different characteristics. In some embodiments, the mounts can be
moveable relative to one another.
[0011] In another exemplary embodiment, a surgical access kit is
provided that includes a hollow tubular member having proximal and
distal ends and a side wall defining a lumen. The hollow tubular
member can be configured to be positioned in an opening in tissue.
In some embodiments, the kit can include at least one tissue
connector configured to secure a portion of the tubular member to
tissue.
[0012] In some embodiments, the surgical access kit can also
include at least one continuous, puncturable seal member removably
and replaceably matable with the tubular member and configured to
seal the lumen. A plurality of access ports can also be provided,
each of which can be configured to mate with the puncturable
membrane at a respective desired location in a sealing engagement.
Each access port can have a sealing element and can be configured
to receive and form a seal around an instrument inserted
therethrough. In some embodiments, at least one of the plurality of
access ports is configured to penetrate the puncturable
membrane.
[0013] In other embodiments, the surgical access kit can also
include at least one modular seal member removably and replaceably
matable with a portion of the tubular member. The seal member can
have at least one mount formed therein that is configured to
receive an access port. A plurality of access ports can also be
provided, each of which can be selectively matable within or on one
of the mounts in a sealing engagement.
[0014] The access ports in any of the embodiments of the surgical
access kit can be configured in any number of ways. For example,
any one or more of the port diameter, port length, port shape, and
port stiffness or the access ports can vary and each of the access
ports can have different characteristics.
[0015] Methods for accessing a body cavity are also provided, and
in one embodiment the method can include inserting a hollow tubular
member within tissue such that a lumen of the hollow tubular member
forms a pathway through the tissue and into a body cavity. The
method can further include mating a modular seal member to a
portion of the tubular member such that the seal member radially
spans the lumen of the tubular member. In some embodiments, a
surgical instrument can be inserted through the modular seal member
to position a distal end of the surgical instrument in the body
cavity. In other embodiments, the method can include mating a
plurality of access ports to the modular seal member and inserting
a surgical instrument through one of the plurality of access
ports.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] The invention will be more fully understood from the
following detailed description taken in conjunction with the
accompanying drawings, in which:
[0017] FIG. 1 is a sectional perspective view of a surgical access
device including a modular seal member and a hollow tubular member
positioned in tissue;
[0018] FIG. 2 is a sectional perspective view of the surgical
access device of FIG. 1 showing the modular seal member mated with
the hollow tubular member;
[0019] FIG. 3 is a sectional perspective view of another embodiment
of a surgical access device including a modular seal member and a
hollow tubular member;
[0020] FIG. 4 is a sectional perspective view of the surgical
access device of FIG. 3 showing a plurality of access ports mated
with the modular seal member;
[0021] FIG. 5 is a sectional perspective view of the surgical
access device of FIG. 4 showing the modular seal member mated with
the hollow tubular member;
[0022] FIG. 6 is a sectional perspective view of another embodiment
of a surgical access device including a hollow tubular member
positioned in tissue;
[0023] FIG. 7 is a sectional perspective view of the surgical
access device of FIG. 6 including a modular seal member;
[0024] FIG. 8 is a sectional perspective view of the surgical
access device of FIG. 7 showing the modular seal member mated with
the hollow tubular member;
[0025] FIG. 9A is a sectional perspective view of another
embodiment of a surgical access device including a hollow tubular
member positioned in tissue and an attachment tool;
[0026] FIG. 9B is a sectional perspective view of the surgical
access device of FIG. 9A showing the attachment tool being mated to
the hollow tubular member;
[0027] FIG. 10A is a perspective view of another embodiment of an
attachment tool being positioned in tissue;
[0028] FIG. 10B is a perspective distal view of the attachment tool
of FIG. 10A showing attachment features in undeployed
positions;
[0029] FIG. 10C is another distal perspective view of the
attachment tool of FIG. 10A showing the attachment features in
deployed positions;
[0030] FIG. 10D is a partial sectional perspective view of the
attachment tool of FIG. 10A showing the attachment features
deployed and engaging tissue;
[0031] FIG. 11A is a side view of one embodiment of an attachment
feature in an undeployed position;
[0032] FIG. 11A is a side view of the attachment feature of FIG.
11A showing rotation of the attachment feature into tissue;
[0033] FIG. 11C is a sectional view of the attachment feature of
FIG. 11B deployed with a cam member disposed in a hollow tubular
member;
[0034] FIG. 12A is a partial sectional perspective view of another
embodiment of a surgical access device including a hollow tubular
member positioned in tissue and an attachment device;
[0035] FIG. 12B is a sectional perspective view of the surgical
access device of FIG. 12A showing the attachment device disposed on
the hollow tubular member;
[0036] FIG. 12C is a sectional perspective view of the surgical
access device of FIG. 12B with housing mechanisms of the attachment
device being activated;
[0037] FIG. 13A is a sectional perspective view of another
embodiment of a surgical access device including a hollow tubular
member and a retractor that is positioned in tissue;
[0038] FIG. 13B is a partial sectional perspective view of another
embodiment of a surgical access device including a hollow tubular
member;
[0039] FIG. 14 is a sectional perspective view of another
embodiment of a surgical access device having an inflatable
anchoring system and being positioned in tissue;
[0040] FIG. 15 is a partial sectional perspective view of the
surgical access device of FIG. 3 showing the mating of a plurality
of access ports with the modular seal member;
[0041] FIG. 16A is a perspective view of an embodiment of an access
port for use with a surgical access device;
[0042] FIG. 16B is a perspective view of another embodiment of an
access port for use with a surgical access device;
[0043] FIG. 16C is a perspective view of another embodiment of an
access port for use with a surgical access device;
[0044] FIG. 16D is a perspective view of another embodiment of an
access port for use with a surgical access device;
[0045] FIG. 16E is a perspective view of another embodiment of an
access port for use with a surgical access device;
[0046] FIG. 17A is a sectional perspective view of another
embodiment of a surgical access device showing insertion of an
access port and the device positioned in tissue;
[0047] FIGS. 17B is another sectional perspective view of another
embodiment of a surgical access device showing insertion of an
access port and the device positioned in tissue;
[0048] FIG. 18 is a partial sectional perspective view of another
embodiment of a surgical access device positioned in tissue and
having adhesive access ports;
[0049] FIG. 19 is a sectional perspective view of another
embodiment of a surgical access device with a plurality of mounts
positioned in tissue;
[0050] FIG. 20A is a perspective view of one embodiment of an
access port for use with a surgical access device;
[0051] FIG. 20B is a sectional perspective view of one embodiment
of a mount for use with a surgical access device;
[0052] FIG. 20C is a sectional side view of the access port of FIG.
20A mated with the mount of FIG. 20B;
[0053] FIG. 21 is a sectional perspective view of another
embodiment of a surgical access device positioned in tissue and
having puncturable regions;
[0054] FIG. 22 is a sectional perspective view of another
embodiment of a surgical access device with independently moveable
mounts;
[0055] FIG. 23A is a perspective view of another embodiment of a
modular seal member having flexible access ports;
[0056] FIG. 23B is a sectional perspective view of another
embodiment of a surgical access device positioned in tissue and
having flexible access ports;
[0057] FIG. 24 is a sectional perspective view of another
embodiment and a surgical access device with an access port being
inserted in the device;
[0058] FIG. 25 is a sectional side view of another embodiment of a
surgical access device positioned in tissue with an access port
being inserted in the device;
[0059] FIG. 26A is a sectional perspective view of another
embodiment of a surgical access device with an access device
positioned in tissue;
[0060] FIG. 26B is sectional perspective view of another embodiment
of a surgical access device with an access device positioned in
tissue;
[0061] FIG. 27 is sectional side view of another embodiment of a
surgical access device with an insufflation port positioned in
tissue;
[0062] FIG. 28A is a sectional side view of another embodiment of a
surgical access device positioned in tissue;
[0063] FIG. 28B is a partial perspective view of the surgical
access device of FIG. 28A;
[0064] FIG. 28C is another partial perspective view of the surgical
access device of FIG. 28A with surgical instruments inserted
through the device;
[0065] FIG. 29 is a perspective view of another embodiment of a
surgical access device;
[0066] FIG. 30A is a perspective view of another embodiment of an
access port;
[0067] FIG. 30B is a perspective view of another embodiment of an
access port positioned in a mount;
[0068] FIG. 31 is a partial sectional perspective view of another
embodiment of a surgical access device showing removal of a modular
seal member;
[0069] FIG. 32 is a sectional perspective view of another
embodiment of a surgical access device positioned in tissue with an
instrument inserted therethrough;
[0070] FIG. 33A is a sectional perspective view of another
embodiment of a surgical access device with a removable specimen
bag being positioned in the device;
[0071] FIG. 33B is a sectional perspective view of the surgical
access device of FIG. 33A with tissue being disposed in the
removable specimen bag; and
[0072] FIG. 33C is a sectional perspective view of the surgical
access device of FIG. 33B with the removable specimen bag having
tissue disposed therein being removed from the device.
DETAILED DESCRIPTION OF THE INVENTION
[0073] Certain exemplary embodiments will now be described to
provide an overall understanding of the principles of the
structure, function, manufacture, and use of the devices and
methods disclosed herein. One or more examples of these embodiments
are illustrated in the accompanying drawings. Those skilled in the
art will understand that the devices and methods specifically
described herein and illustrated in the accompanying drawings are
non-limiting exemplary embodiments and that the scope of the
present invention is defined solely by the claims. The features
illustrated or described in connection with one exemplary
embodiment may be combined with the features of other embodiments.
Such modifications and variations are intended to be included
within the scope of the present invention.
[0074] The present invention generally provides improved surgical
access devices and methods. In use, the surgical access devices
disclosed herein can provide access through tissue into a patient's
body cavity. The device can include a number of different
components, but generally includes a hollow tubular member that can
be positionable within an opening in a patient's body and a modular
seal member that is configured to radially span a lumen of the
tubular member. The access device can also include a plurality of
access ports, each of which can be configured to mate with the
modular seal member at a respective desired location.
[0075] A person skilled in the art will appreciate that the access
device can be placed in any opening within a patient's body,
whether a natural orifice or an opening made by an incision. For
non-limiting example, the access device can be placed through the
umbilicus, endoscopically including, vaginally, percutaneously,
etc. The elasticity of the skin of the patient can assist in the
retention of the access device in the body opening or incision made
in the body. In one embodiment, the access device can be
substantially flexible so that it can easily be maneuvered into
tissue as needed. In such an embodiment, the access device can
include a rigid housing or support structure. In other embodiments,
the access device can be rigid or semi-rigid. The access device can
be formed of any suitable material known in the art, for example
silicone, urethane, thermoplastic elastomer, and rubber. In other
aspects, the durometer of the materials used to form the access
device can vary in different portions of the device. For
non-limiting example, a portion of the device that can mate with
the modular seal member can be more rigid than a portion of the
sidewall of the device.
[0076] Typically, during surgical procedures in a body cavity, such
as the abdomen, insufflation is provided through the surgical
access device to expand the body cavity to facilitate the surgical
procedure. Thus, in order to maintain insufflation within the body
cavity, most surgical access devices include at least one seal
disposed therein to prevent air and/or gas from escaping when
surgical instruments are inserted therethrough. Various sealing
elements are known in the art, but typically the surgical access
device can include at least one instrument seal that forms a seal
around an instrument disposed therethrough, but otherwise does not
form a seal when no instrument is disposed therethrough; at least
one channel seal or zero-closure seal that seals the working
channel created by the sealing port when no instrument is disposed
therethrough; or a combination instrument seal and channel seal
that is effective to both form a seal around an instrument disposed
therethrough and to form a seal in the working channel when no
instrument is disposed therethrough. A person skilled in the art
will appreciate that various seals known in the art can be used
including, e.g., duckbill seals, cone seals, flapper valves, gel
seals, diaphragm seals, lip seals, iris seals, etc. A person
skilled in the art will also appreciate that any combination of
seals can be included in any of the embodiments described herein,
whether or not the seal combinations are specifically discussed in
the corresponding description of a particular embodiment. Exemplary
embodiments of various seal protectors are described in more detail
in U.S. Pat. No. 5,342,315 entitled "Trocar Seal/Protector
Assemblies," issued Aug. 30, 1994 and U.S. Pat. No. 7,163,525
entitled "Duckbill Seal Protector," issued Jan. 16, 2007, which are
hereby incorporated by reference in their entireties.
[0077] Any and all embodiments of a surgical access device can also
include one or more safety shields positioned through, in, and
around any of the components and/or tissue to protect the
components against puncture or tear by surgical instruments being
inserted through the device. Exemplary embodiments of safety
shields are described in more detail in U.S. Patent Publication No.
2006/0247673 entitled "Multi-port Laparoscopic Access Device" filed
Nov. 2, 2006, U.S. patent application Ser. No. 12/399,625 entitled
"Methods and Devices for Providing Access to a Body Cavity" filed
on Mar. 6, 2009, U.S. patent application Ser. No. 12/399,482
entitled "Methods and Devices for Providing Access to a Body
Cavity" filed on Mar. 6, 2009, and U.S. patent application Ser. No.
12/242,765 entitled "Surgical Access Device" filed on Sep. 30,
2008, which are hereby incorporated by reference in their
entireties.
[0078] In any and all of the surgical access device embodiments
disclosed herein, an engagement and/or release mechanism can be
included to allow certain components of the surgical access device
to be removable as needed, such as removable coupling seal member.
Any engagement and release mechanism known in the art, e.g., a
snap-lock mechanism, corresponding threads, etc., can be used to
releasably mate components of the device. Exemplary embodiments of
an engagement and release mechanisms are described in more detail
in previously mentioned U.S. patent application Ser. No. 12/242,765
entitled "Surgical Access Device" filed on Sep. 30, 2008, U.S.
patent application Ser. No. 12/399,625 entitled "Methods and
Devices for Providing Access to a Body Cavity" filed on Mar. 6,
2009, and U.S. patent application Ser. No. 12/399,482 entitled
"Methods and Devices for Providing Access to a Body Cavity" filed
on Mar. 6, 2009 and in U.S. Pat. No. 7,371,227 entitled "Trocar
Seal Assembly," issued May 13, 2008 and U.S. Pat. No. 5,628,732
entitled "Trocar With Improved Universal Seal," issued May 13,
2007, which are hereby incorporated by reference in their
entireties.
[0079] FIGS. 1 and 2 illustrate one exemplary embodiment of a
surgical access device 10 that generally includes a hollow tubular
member 12 and a modular seal member 14. The hollow tubular member
12 includes a distal end 16d, a proximal end 16d, and a side wall
16s that extends between the distal and proximal ends. The sidewall
16s defines a lumen or working channel 18 through which instruments
can be inserted from outside the body to an interior body cavity.
The hollow tubular member can have any diameter, e.g., between
about 10 to 60 mm, and any length, e.g., between about 1.5 to 7
cm.
[0080] In some embodiments, the proximal end of the hollow tubular
member can include a proximal rim or flange that extends radially
outward from a proximal end of the hollow tubular member such that
the diameter of the proximal rim can be larger than a nominal
diameter of the hollow tubular member. In the embodiment shown in
FIGS. 1 and 2, the proximal end 16p of the hollow tubular member 12
includes a proximal rim or flange 20 that can be seated against a
tissue surface S. The proximal rim 20 can have a variety of
configurations, but can generally be effective to prevent the
hollow tubular member 12 from passing through an incision in tissue
or through a natural orifice into which the hollow tubular member
12 can be inserted. In some embodiments, the rim 20 can be used to
anchor the hollow tubular member 12 to tissue using, for
non-limiting example, adhesive applied to a distal surface 20d of
the rim or flange 20. In other embodiments, the rim 20 can be used
in conjunction with an anchoring mechanism, as discussed in more
detail below. As illustrated, the proximal rim 20 can include a
ridge 21 that can increase the stiffness and strength of the
proximal end 16p of the hollow tubular member 12.
[0081] In some embodiments, the distal end 16d of the hollow
tubular member 12 can also include a rim or flange 22. For example,
the distal rim 22 can extend radially inward from the proximal end
16d of the hollow tubular member 12 as shown in FIGS. 1 and 2. The
distal rim 22 can have a variety of configurations, as will be
discussed in more detail below. In the embodiment shown in FIGS. 1
and 2, the distal rim 22 seats a connection member 24. As shown in
the illustrated embodiment, the connection member 24 includes a
ring 26 seated on the distal rim 22. However, the connection member
24 can have any number of configurations and can be connected to
the distal end 16d of the hollow tubular member 12 in any number of
ways. For non-limiting example, the connection member 24 can be
connected to the hollow tubular member 12 using a snap-fit, an
interference fit, threaded connections, adhesive connections,
bayonet connectors, etc. The connection member 24 can be configured
to mate with the modular seal member 14.
[0082] The modular seal member can also have any number of
configurations. As shown in the embodiment illustrated in FIGS. 1
and 2, the modular seal member 14 can include an outer ring 28 and
a continuous puncturable membrane 30. The outer ring 28 can have
any number of configurations. As shown in the illustrated
embodiment, the outer ring 28 can include a groove 28g formed by a
first lip 32 and a second lip 33. The first and second lips 32, 33
can be configured in any number of ways. For non-limiting example,
the second lip 33 can have a larger diameter than the first lip 32,
although any other configuration is possible. The first and second
lips 32, 33 can also be flexible so as to allow the lips to deform
when the modular seal member 14 is inserted or removed from the
hollow tubular member. The groove 28g and lips 32, 33 can engage
the hollow tubular member 12, for example, at the distal end 16d of
the hollow tubular member 12 by engaging the distal rim 22 or the
connection member 24. The engagement can be achieved in any number
of ways, some exemplary embodiments of which will be discussed in
more detail below. In the embodiment of FIGS. 1 and 2, the groove
28g of the outer ring 28 of the modular seal member 14 engages the
distal rim 22 of the hollow tubular member 12 and is retained
thereon by the lips 32, 33. The outer ring 28 can also include a
tab 28t that can be used configured as a handhold for the modular
seal member 14 during insertion and removal from the hollow tubular
member 12. The tab 28t can also be used in releasing the lips 32,
33 from engagement with the hollow tubular member 12 and/or
connection member 24.
[0083] The continuous puncturable membrane 30 disposed in the
modular seal member 14 can have any number of configurations. For
non-limiting example, the membrane 30 can be formed from a
resilient material that can be punctured by an instrument or other
implement without tearing or ripping the membrane 30, e.g., latex,
silicone rubber, neoprene, polypropylene, polyethylene, isoprene,
sanoprene, polyurethane, etc. The continuous puncturable membrane
30 can be joined to the outer ring 28 to form the modular seal
member 14 in any number of ways, such as by bonded to the ring 28
with adhesive, ultrasonic welding, heat, etc. In some embodiments,
the continuous puncturable membrane 30 can be injection molded onto
the ring 28.
[0084] In use, the hollow tubular member 12 can be inserted into an
opening in tissue. The opening can extend through the tissue to
fascia F of the patient's body, as shown in the embodiment in FIGS.
1 and 2, or the opening can extend through the fascia F. As
discussed above, the proximal rim 20 can act as a stop to prevent
the hollow tubular member 12 from passing through the opening. In
some embodiments, the modular seal member 14 can be mated to the
hollow tubular member 12 before insertion. In other embodiments the
hollow tubular member 12 can be positioned in the tissue and then
the modular seal member 14 can be mated to the hollow tubular
member 12. Insertion of the hollow tubular member 12 into tissue
without the modular seal member 14 connected thereto can allow
visualization of the tissue opening's depth and confirmation that
the hollow tubular member 12 is properly seated against the fascia
F.
[0085] Any of the surgical access devices described herein, such as
the device of FIGS. 1 and 2, can be positioned within tissue to
provide access to a body cavity underlying the tissue. In one
embodiment a hollow tubular member 12 can be positioned within a
tissue opening such that a lumen of the hollow tubular member 12
forms a pathway through the tissue and into a body cavity. The
modular seal member 14 can be mated to a portion of the tubular
member 12 either before or after the tubular member 12 is
positioned within tissue such that the seal member 14 radially
spans the lumen 18 of the tubular member 12. In some embodiments, a
surgical instrument can be inserted through the modular seal member
14 to position a distal end of the surgical instrument in the body
cavity. In other embodiments, at least one access port can be mated
to the modular seal member 14 and a surgical instrument can be
inserted through any one or more of the access ports.
[0086] The surgical access device 10 can be positioned within an
opening formed in the tissue, e.g., in the umbilicus, with the
proximal end of the hollow tubular member 12 positioned on the a
proximal surface of the tissue. With the surgical access device 10
positioned in the tissue with the modular seal member 14 in place,
one or more surgical instruments can be inserted therethrough and
into the body cavity, as discussed above, where the instruments can
help perform any type of surgical procedure. Any surgical device
such as a grasper, a scoping device (e.g., an endoscope, a
laparoscope, and a colonoscope), a cutting instrument, etc., can be
inserted through the device. A person skilled in the art will
appreciate that the term "grasper" as used herein is intended to
encompass any surgical instrument that is configured to grab and/or
attach to tissue and thereby manipulate the tissue, e.g., forceps,
retractors, movable jaws, magnets, adhesives, stay sutures, etc. A
person skilled in the art will also appreciate that the term
"cutting instrument" as used herein is intended to encompass any
surgical instrument that is configured to cut tissue, e.g., a
scalpel, a harmonic scalpel, a blunt dissector, a cautery tool
configured to cut tissue, scissors, an endoscopic linear cutter, a
surgical stapler, etc.
[0087] In another embodiment illustrated in FIGS. 3, 4, and 5, a
connection member 324 of a surgical access device 310 can include
attachment features 334 that can lock the hollow tubular member 312
to tissue. The attachment features 334 can be configured in any
number of ways. In an exemplary embodiment, the attachment features
334 can be formed as hooks. As illustrated in one embodiment in
FIGS. 11A and 11B, hooks 1100 can include a pivot point 1102, a
notch 1104, and a pointed engagement region 1106. The hooks 1100
can be rotated by any number of mechanisms. In one embodiment, cam
mechanisms can be configured to rotate the hooks 1100 in the
direction of the arrow shown in FIG. 11B and into engagement with a
tissue surface. FIG. 11C shows an exemplary embodiment of a cam
mechanism 1110. The notch 1104 of a hook 1100 can provide a camming
surface that can be engaged by a pin 1112 of the cam mechanism 1110
so as to rotate the hook 1100 in response to a linear movement of
the pin 1112 from a first position (shown in FIG. 11A) to a second
position (shown in FIGS. 11B and 11C). Although the notch 1104 can
have any shape and size and be oriented within the hook 1100 in any
number of ways, the notch 1104 can be configured such that the hook
1100 is biased to the deployed position when the pin 1112 is in the
second position. In the exemplary embodiment of FIGS. 3, 4, 5, the
attachment features 334, such as the hook 1100 of FIGS. 11A and
11B, can be configured to distally extend from a distal surface of
the surgical access device 310 so as to anchor the device 310 to
tissue. However, in other exemplary embodiments, such as one
illustrated in FIG. 8, attachment features 634 can be configured to
extend approximately perpendicular to a sidewall 616s of a hollow
tubular member 612. In the embodiments of FIG. 8, the attachment
features 634 can engage tissue proximal to the distal end of the
tubular member to anchor the device 610. FIGS. 9A and 9B, discussed
below, also show approximately perpendicularly extending attachment
features 934.
[0088] As shown in the illustrated embodiment of FIGS. 3-5, the
attachment features 334 can engage fascia and can pass through
openings in a distal rim 322 of the device 310, thereby locking the
connection member 324 and the hollow tubular member 312 to the
fascia F. The device 310 includes another embodiment of a modular
seal member 314 configured to engage the hollow tubular member 312
and that includes a continuous penetrable membrane 330, an outer
ring 328, and a tab 328t. As shown, the ring 328 can include a lip
329 configured to engage the connection member 324. The lip 329 can
be continuous around the circumference of the ring 328 or it can be
discontinuous, forming a series of tabs.
[0089] FIG. 4 shows the device of FIG. 3 with the addition of a
plurality of access ports 341, 342, 343, inserted through the
continuous puncturable membrane 330. FIG. 5 shows the modular seal
member 314 of FIG. 4 including a plurality of access ports 341,
342, 343 mated with the hollow tubular member 312. As shown, the
access ports 341, 342, 343 can provide access to a body cavity
through the hollow tubular member 312 when the fully assembled
device 310 is positioned in a tissue opening.
[0090] The access ports 341, 342, 343 are exemplary embodiments but
can have a variety of other shapes, sizes, and configurations. FIG.
15 illustrates other exemplary embodiments of access ports 341',
342', 343' that can be inserted through a puncturable membrane 330'
similar to the membrane 330 of FIGS. 3-5. The access ports 341',
342', 343' can be configured in any number of ways, such as being
threaded. As shown, the access ports 341', 342', 343', using one
access port 341' as an example, can each have a distal end 341d, a
proximal end 341p, and a generally cylindrical body 341b extending
between the ends 341d, 341p. The cylindrical body 341b can be
hollow to allow an instrument to be inserted therethrough and can
include various sealing elements such as, for non-limiting example,
duckbill seals, cone seals, flapper valves, gel seals, diaphragm
seals, lip seals, iris seals, etc. In some embodiments, threads
341t can be disposed on a distal portion of the cylindrical body
341b. The threads 341t can terminate at a circumferential lip 341 L
proximal to the threads 341 t such that the access port 341' can
have a proximal threadless portion 345. The proximal end 341p of
the access port 341' can have a larger diameter than the
cylindrical body 341b and can include a seal housing 341s.
[0091] The seal housing 341s can have a variety of configurations
and can include a variety of one or more seal elements that are
effective to seal the working channel of the housing when no
instrument is disposed therein and/or to form a seal around an
instrument disposed therethrough. The seal elements can be
particularly useful to prevent gases from escaping through the
access port and the housing to maintain the insufflation of the
body cavity. Various seals are known in the art, but typically the
surgical access device can include at least one instrument seal
that forms a seal around an instrument disposed therethrough, but
otherwise does not form a seal when no instrument is disposed
therethrough; at least one channel seal or zero-closure seal that
seals the working channel when no instrument is disposed
therethrough; or a combination instrument seal and channel seal
that is effective to both form a seal around an instrument disposed
therethrough and to form a seal in the working channel when no
instrument is disposed therethrough. A person skilled in the art
will appreciate that various seals known in the art can be used
including, e.g., duckbill seals, cone seals, flapper valves, gel
seals, diaphragm seals, lip seals, iris seals, etc.
[0092] In some embodiments the distal ends of the access ports
341', 342', 343' can include a sharp tip that can puncture the
membrane 330' and/or cut through tissue. In use, the access ports
341', 342', 343' can be inserted through the puncturable membrane
330' by rotating the access ports 341', 342', 343' in the
counterclockwise direction of the arrow shown in FIG. 15, although
any of the access ports 341', 342', 343' can be configured for
clockwise insertion rotation. In some embodiments the modular seal
member 314' can be disposed within and mated to the hollow tubular
member 312' prior to insertion of the access ports 341', 342',
343'. If this is the case, then rotation of an access port can
advance the access port through the puncturable membrane and
through tissue to provide access to the body cavity. The access
ports 341', 342', 343' can be advanced through the puncturable
membrane 330' until the access port's circumferential lip passes
through the membrane 330'. The circumferential lips can retain
their respective access ports 341', 342', 343' within the membrane
330', thereby providing a seal around the access ports 341', 342',
343'.
[0093] FIGS. 16A to 16E illustrate other embodiments of access
ports having retaining features. Each access port shown in FIGS.
16A to 16E includes a hollow, generally cylindrical body extending
between a distal end and a proximal end with the distal ends each
including a sharp truncated tip that can enable the access port to
be inserted through the puncturable membrane and/or the fascia
layer. Also as discussed above, the proximal ends, as shown, can
have a larger diameter than the respective cylindrical bodies and
can include a seal housing. FIG. 16A to 16C show various surface
features disposed on the cylindrical body of the access port. The
various surface features can retain the access port within the
puncturable membrane and/or the fascia layer. For non-limiting
example, a series of conical projections 162a can surround the
generally cylindrical body 164a of the access port 160a, as shown
in FIG. 16A. Alternatively, a series of annular projections 162b
can surround the generally cylindrical body 164b of the access port
160b, as shown in FIG. 16B. FIG. 16C shows another embodiment in
which threads 162c can be disposed around the generally cylindrical
body 164c of the access port 160c. Other means of retaining an
access port within the surgical access device are also possible.
For non-limiting example, FIG. 16D shows an access port 160d
including an expandable balloon 162d disposed near the distal end
165 of the access port 160d. The expandable balloon 162d can be
inflated via an input line 166d using any fluid or gas. The balloon
162d can be affixed to the cylindrical body 164d using any means
known in the art. In another embodiment, shown in FIG. 16E, suction
can be provided through orifices 166 in a housing 168 surrounding
the cylindrical body 164e of the access port 160e. The housing 168
can be in fluid communication with an output line 166e that can be
connected to any suction means known in the art.
[0094] In another embodiment, an access port can be inserted
through the continuous puncturable membrane and retained therein by
expandable retention features. For example, in an exemplary
embodiment illustrated in FIGS. 17A and 17B, which shows a surgical
access device 710, similar to those described in more detail above,
an access port such as a cannula 740 can have a tip region 742
configured to anchor the cannula 740 to the continuous puncturable
membrane 730, an elongate shaft region 744, and a proximal seal
region 746. However, the cannula 740 can be configured in any
number of ways that will be appreciated by one skilled in the art.
Although the tip region 742 can also have numerous configurations,
in the illustrated embodiment the tip region 742 includes a distal
sharpened tip 748, an expandable collar 750, and a clamping collar
752. The cannula 740 can be advanced until the expandable collar
750 passes through the membrane 730 and/or the fascia F. As the tip
region 742 passes through an opening formed by the sharpened tip
748, the expandable collar 750 can be compressed to fit through the
opening and the cannula 740 can be advanced until the clamping
collar 752 contacts the puncturable membrane 730. The expandable
collar 750 can then expand to a larger diameter than the hole
produced by the sharpened tip 748, as shown in FIG. 17B. The larger
diameter of the expandable collar 750 can act to retain the cannula
740 within the opening. The clamping collar 752 can provide a seal
against the puncturable membrane 730 to prevent escape of fluid or
other material, such as insufflation gases, through the opening in
the puncturable membrane 730.
[0095] In some embodiments, access ports can be affixed to the
continuous puncturable membrane. In these embodiments, the access
ports do not necessarily penetrate the puncturable membrane. In one
exemplary embodiment shown in FIG. 18, one or more access ports
840, 841, 842, 843 can be affixed to a continuous puncturable
membrane 830 of a surgical access device 810 similar to those
described in more detail above. The access port 840, 841, 842, 843
can be affixed to the continuous puncturable membrane 830 using any
attachment mechanism, e.g., an adhesive. For non-limiting example,
each access port 840, 841, 842, 843 can be provided with an
adhesive layer 850, 851, 852 (not shown for access port 843) on a
distal surface thereof that can be optionally initially protected
by an adhesive backing 860 (only shown for access port 840). When
the backing 860 is removed from the access port 840 or adhesive is
otherwise exposed, the adhesive layers 850, 851, 852 can be used to
mate, join, or affix the access port 840, 841, 842, 843 to the
continuous puncturable membrane 830 at respective desired
locations. The adhesive can be any adhesive known in the art, e.g.,
cyanoacrylate, urethane, epoxy, etc. The adhesive 850, 851, 852 can
be configured to mate the access port 840, 841, 842, 843 to the
puncturable membrane 830 with a bond of sufficient strength to
allow an instrument to be inserted through an access port to be
manipulated without detaching the access port from the puncturable
membrane 830. As shown in FIG. 18, a plurality of access ports 840,
841, 842, 843 can be affixed to the puncturable membrane 830 at
various positions to provide customizable access to a body cavity.
The access ports 840, 841, 842, 843 can include various sealing
elements so as to provide a seal around an inserted instrument. An
inserted instrument can pass through one or more sealing elements
of the access port and pass through the puncturable membrane 830,
and the fascia F if present, to reach a body cavity underlying
tissue in which the device 810 is positioned.
[0096] In another embodiment of a surgical access device shown in
FIGS. 6-8, a hollow tubular member of a surgical access device 610
can include a number of projections 650 that can engage
complementary projections or grooves on a connection member 624.
The projections 650 can be configured in any number of ways, e.g.,
configured such that rotation of the connection member 624 relative
to the hollow tubular member 612 can bring the projections 650 of
the hollow tubular member 612 and the connection member 624 into
engagement with complementary projections or grooves (not shown) on
the connection member 624, thereby mating the connection member 624
to the hollow tubular member 612, as shown in FIG. 8. Rotation of
the connection member 624 can be accomplished in any number of
ways. For non-limiting example, an attachment tool can be used to
rotate the connection member relative to the hollow tubular member.
The attachment tool can have a variety of configurations. In one
exemplary embodiment shown in FIGS. 9A and 9B, an attachment tool
900 can engage a connection member 924. As in the illustrated
embodiment, the attachment tool 900 can have a generally
cylindrical body 902 including a proximal handle 904 and one or
more distal heads 906. The attachment tool 900 can be hollow to
reduce weight and to provide an increased field of view. The
attachment tool 900 can rotate the connection member 924 to engage
projections 650 (FIG. 7) on the connection member 924 with the
hollow tubular member 912. As illustrated in FIG. 9B, the distal
heads 906 can extend into one or more slots 914 formed in the
connection member 924. The heads 906 can engage various features of
the connection member 924 when they are inserted into the slots
914. For non-limiting example, when the tool 900 is rotated in the
direction of the arrows shown in FIG. 9B, the heads 906 can engage
at least one attachment feature 934 within the connection member
924. For non-limiting example, the tool 900 can deploy attachment
features 934, e.g., the hooks 1100 discussed above and shown in
FIGS. 11A and 11B.
[0097] In some embodiments, an attachment tool can be configured to
be removably mated to a connection member so that the attachment
tool can be used to insert a surgical access device into an opening
in tissue, as shown in an exemplary embodiment illustrated in FIGS.
10A-10D. As shown, an attachment tool 1000 can include an anchoring
mechanism 1010 configured to be actuated by rotation of the
attachment tool 1000. For non-limiting example, a distal surface of
the anchoring mechanism 1010 can include a series of
counter-traction gripper teeth 1014 having any size, shape, and
orientation on the distal surface. The gripper teeth 1014 can be
configured to help prevent the anchoring mechanism 1010 from moving
or rotating with respect to underlying tissue, such as the fascia
layer, when the attachment tool 1000 is rotated. When the
attachment tool 1000 is rotated relative to the anchoring mechanism
1010, an attachment feature such as a series of hooks 1016 can be
deployed to engage tissue. For non-limiting example, the hooks 1016
can extend from the distal surface 1012 of an anchoring mechanism
1010 from an undeployed position, shown in FIG. 10B, to a deployed
position, shown in FIG. 10C. When deployed, the hooks 1016 can help
anchor a surgical access device to tissue by gripping and/or
penetrating the tissue, thereby preventing unwanted movement during
use as shown, for non-limiting example, in FIG. 10D.
[0098] FIGS. 12A to 12C illustrate another exemplary embodiment of
a surgical access device 210 that includes a flexible retractor
260, a hollow tubular member 212, and a retaining ring 270. In
general, the retractor 260 can be configured to be disposed within
a tissue opening to form a working channel through tissue T and
into a body cavity underlying the tissue T. Although generally
referred to as a retractor herein, the retractor can variously be
referred to as a wound protector, cannula, ring retractor, or any
other member configured to form a pathway through tissue. The
retractor 260 can provide access to an interior surgical site
within a body cavity and can include proximal and distal ends 260p,
260d and a working channel extending therebetween in a cylindrical
mid-portion 260m. The proximal and distal ends 260p, 260d of the
retractor 260 can have any suitable configuration that allow the
retractor 260 to be secured within the opening. The proximal and
distal ends 260p, 260d are depicted as having an annular shape, but
they can have any configuration including and without limitation, a
circular, oval, elliptical, square, and rectangular configuration.
Additionally, the proximal and distal ends 260p, 260d need not be
closed or continuous but can, for example, include a plurality of
circumferentially-spaced, radially-extending tabs (not shown).
[0099] The hollow tubular member 212 can be seated within the
working channel of the retractor 260. One skilled in the art will
appreciate that the retractor 260 can have any number of
configurations, shapes, and sizes depending at least in part on a
size of the incision or opening in which the retractor 260 will be
disposed, the surgical components with which it will be used,
and/or the type of surgical procedure with which it will be used.
In an exemplary embodiment, the retractor 260 can be positioned
within an opening in tissue such that the distal end 260d of the
retractor extends into a patient's body cavity or is adjacent to an
inner surface of the tissue with the proximal end 260p of the
retractor positioned adjacent to the patient's skin on an exterior
surface of the patient's body. The retractor's working channel
provides a pathway through the tissue through which surgical
instruments can be inserted from outside the body to the interior
body cavity.
[0100] The retaining ring of the device can be configured in a
variety of ways. In the exemplary embodiment illustrated in FIGS.
12A to 12C, the retaining ring 270 can be circular and can have at
least one clip housing 250. The clip housing 250 can include a
mechanism 252 configured to actuate an attachment mechanism such as
a hook 280 similar to the hooks described above. Any number of clip
housings 250 can be disposed around the circumference of the
retaining ring 270, and they can be spaced around the retaining
ring 270 in any number of ways. For non-limiting example, as in the
illustrated embodiment, four clip housings 250 can be provided that
are spaced equidistant from one another around the circumference of
the retaining ring 270. In use, the retaining ring 270 can be
applied to the proximal end of the hollow tubular member 212, as
shown in FIG. 12B. The clip housing mechanisms 252 can then be
actuated as shown in FIG. 12C. Actuation of the clip housings 250
via mechanisms 252 can deploy the hooks 280 such that they pass
through the proximal end of the hollow tubular member 212, e.g.,
through pre-formed openings, and into the tissue T, thereby
anchoring the surgical access device 210 to the tissue T.
[0101] In another embodiment shown in FIG. 13A, a surgical access
device 1310 can include a two-part retractor 1360 that includes a
proximal ring 1364 and a distal retractor tube 1362. These
components can be configured in any number of ways, but in an
exemplary embodiment the proximal ring 1364 can be configured to be
seated against a tissue surface S and the distal retractor tube
1362 can be configured to sit within an opening in tissue. The
proximal ring 1364 and distal retractor tube 1362 can be mated to
each other. In some embodiments the proximal ring 1364 can be rigid
and the distal retractor tube 1362 can be flexible, although one
skilled in the art will appreciate that other variations are
possible. As illustrated in FIG. 13A, the outer surface of the
retractor tube 1362 can include ribs, threads, or other engagement
features 1362r to aid in retaining the retractor within an
incision. In use, a hollow tubular member 1312 can be inserted at
least partially into a working channel of the assembled retractor
1360 and can engage the retractor 1360 in any number of ways such
as by being seated in the proximal ring 1364 and extending into the
retractor tube's working channel.
[0102] Another exemplary embodiment of a hollow tubular member is
illustrated in FIG. 13B. In this embodiment, the outer surface of a
hollow tubular member 1313 can include ribs, threads or other
engagement features. These engagement features, such as
circumferentially spaced threads 1313t shown in FIG. 13B, can be
configured to retain the hollow tubular member 1313 within a tissue
opening O and/or within a retractor (not shown). In use, the hollow
tubular member 1313 can be rotated to advance the hollow tubular
member 1313 into the tissue opening O or the retractor to provide a
working channel through tissue through which instruments can be
inserted.
[0103] In yet another exemplary embodiment of a surgical access
device shown in FIG. 14, a hollow tubular member 1412 can be
retained within an opening in tissue using an inflatable bladder
1430. Although the illustrated embodiment depicts the hollow
tubular member 1412 and a two-part retractor 1460 similar to that
shown in FIG. 13A, one skilled in the art will appreciate that an
inflatable bladder 1430 can be used to retain any hollow tubular
member within an opening with or without use of a retractor. The
inflatable bladder 1430 can be mated to and extend from a
connection member 1424 mated to a distal end of the hollow tubular
member 1412. The bladder 1430 can have any configuration, such as
an annular bladder that, when inflated, expands to a configuration
having a diameter larger than a diameter of the hollow tubular
member. The bladder can be expanded in any way, such as by
inflation from a tube 1432 that can pass through a portion of the
connection member 1424. As shown in FIG. 14, when the device
including the hollow tubular member having the bladder 1430 is
positioned in an opening tissue and the bladder 1430 is expanded,
the bladder 1430 can be positioned within a body cavity underlying
the tissue against an interior surface of the patient's fascia F.
In this way, the inflated or expanded bladder 1430 can retain the
hollow tubular member 1412 within the opening in tissue.
[0104] In another exemplary embodiment of a surgical access device
910 shown in FIG. 19, a modular seal member 914 of the device 910
can include one or more mounts 920. The mounts 920 can surround
openings 922 formed in the modular seal member 914. Although the
mounts 920 can be configured in any number ways and can have any
size and shape, in the illustrated embodiment the mounts 920 each
include a generally cylindrical sidewall 920s extending proximally
from the modular seal member 914. Each mount 920 can include an
access port 920p mated to the mount 920. As discussed above, the
access port 920p can provide a seal around an inserted instrument
(not shown). Although in the illustrated embodiment the modular
seal member 914 is shown mated to a hollow tubular member 912 that
is disposed within a flexible retractor 960 similar to the
embodiment of FIGS. 12A to 12C discussed above, one skilled in the
art will appreciate that a modular seal member 914 of the type
shown in of FIG. 19 can be used with any of the various hollow
tubular members and anchoring mechanisms disclosed herein.
[0105] FIGS. 20A to 20C show another exemplary embodiment of an
access port 2010 and a mount 2020, similar to of FIG. 19. The
access port 2010 can include a sealing element 2022 and a retaining
member 2024. The sealing element 2022 can be configured in any
number of ways, but in the illustrated exemplary embodiment the
sealing element 2022 can span an opening 2026 in the retaining
member 2024. The retaining member 2024 can likewise be configured
in any number of ways, but as in this exemplary embodiment the
retaining member can be generally cylindrical in shape and can have
an opening 2026 formed therethrough. The opening 2026 can also be
any shape, such as in the illustrated embodiment where the opening
2026 has a generally circular shape with at least one region 2028
of larger diameter. In use, the region 2028 of larger diameter can
provide increased range of motion for an inserted instrument
without compromising the seal provided by the access port 2010.
Although the mount 2020 can be configured in any number ways and
can have any shape, as in the illustrated embodiment the mount can
include a generally cylindrical sidewall 2020s that extends
proximally from a surface 2030, such as a surface of a modular seal
member. The sidewall 2020s can define an opening 2021 in the
surface 2030 and can terminate in a flange 2020f that can extend
circumferentially around the sidewall 2020s. The mount 2020 can be
rigid or flexible. As shown in FIG. 20C, the access port 2010 can
be coupled to a mount 2020, although the access port 2010 can be
mated to any mount, and vice versa. The sealing element 2022 can
thereby span the opening 2021 in the mount 2020 to provide a seal
around instruments inserted through the mount 2020. Although FIG.
20C shows the mount 2020 and access port 2010 with space
therebetween, in use the sealing element 2022 and retaining member
2024 of the access port 2010 can fit tightly against the mount 2020
and its flange 2020f to provide a seal to prevent escape of fluid
or other material, such as insufflation gases.
[0106] FIG. 21 shows another exemplary embodiment of a surgical
access device 2110 that includes a hollow tubular member 2112 and a
modular seal member 2114. In this embodiment, the modular seal
member 2114 can include flexible puncturable regions 2130. For
non-limiting example, more than one puncturable region 2130 can be
formed within a more rigid modular seal member 2114. The
puncturable regions 2130 can be formed by removing a portion of the
modular seal member 2114 to form an opening which can then be
spanned by a puncturable membrane similar to the puncturable
membranes discussed above. As shown, the puncturable region 2130
can be retained within an opening in the modular seal member 2114
by proximal and distal rings 2140p, 2140d that can be bonded to the
seal member 2124 and/or the puncturable region 2130. The rings
2140p, 2140d can be bonded using any technique known in the art
such as, heat welding, adhesives, ultrasonic welding, etc.
Alternatively, the puncturable region 2130 can be formed as an
integral part of the modular seal member 2114 by any technique,
e.g., injection molding, etc. Any number of puncturable regions
2130 can be provided in the modular seal member 2114 along with any
of the other sealing elements discussed herein, e.g., sealing
elements disposed on mounts, adhesively mounted sealing elements,
etc. In use, an instrument I can be inserted through any of the
puncturable regions 2130 of the modular sealing element 2114 to
provide access to the body cavity. Although only one instrument I
is shown inserted through the device 2110, as with any surgical
access device described hereon, multiple instruments can be
simultaneously and/or sequentially inserted therethrough.
[0107] FIG. 22 illustrates another exemplary embodiment of a
surgical access device 2210 that includes a hollow tubular member
2212 and a modular seal member 2214. In this embodiment, the
modular seal member can include several access ports 2120, each of
which can move independently relative to each other. The
independently moveable access 2120 ports can be configured in any
number of ways. As in the illustrated embodiment, each access port
2120 can be disposed on an independently moveable concentric ring
2116a, 2116b, 2116c, each of which can rotate independently from
the other rings 2116a, 2116b, 2116c. In this manner, each access
port 2120 can move independently, thereby providing increased
maneuverability of instruments inserted through the access ports
2120. The access ports 2120 can be formed according to any of the
embodiments discussed herein such as, for example, access ports
with sealing elements disposed on mounts, access ports with
adhesively mounted sealing elements, etc.
[0108] FIGS. 23A and 23B illustrate yet another exemplary
embodiment of a surgical access device 2310 that includes a hollow
tubular member 2312, a modular seal member 2314, and one or more
access ports 2341. In this embodiment, the access ports 2341 can be
connected to the modular seal member 2314 by flexible connectors
2342 that can allow the access ports 2341 to move polyaxially and
to longitudinally extend relative to the modular seal member 2314.
For non-limiting example, as illustrated in this embodiment, the
flexible connector 2342 can be a tubular member that can include
one or more bellows that can fold and unfold, thereby allowing the
tubular member to flex and extend. FIG. 23A also illustrates an
exemplary embodiment of a modular seal member 2314 that can include
mounts 2320 or access ports that vary in size or diameter with
respect to the other mount(s) or access port(s).
[0109] FIG. 24 illustrates another exemplary embodiments of a
surgical access device 2410 that includes a hollow tubular member
2412, a modular seal member 2414, and one or more access ports
2441. In this embodiment, a trocar 2470 that includes a pointed tip
2472, an elongate shaft 2474, and a proximal seal housing 2476 can
be configured to be inserted through an access port 2441 in the
modular seal member 2414. As shown, the seal housing 2476 can be
mated to the access port 2441 using one or more tabs 2470t. The
tabs 2470t can engage a complementary slot 2441s in the access port
2441 when the seal housing 2476 is rotated, thereby retaining the
seal housing 2476 in the access port. In use, the pointed tip 2472
of the trocar 2470 can puncture the modular seal member 2414 or a
seal within an access port, and/or the fascia, if present. The
trocar 2470 can then pass into a body cavity until the seal housing
2476 makes contact with the access port 2414. The trocar 2470 can
then be removed from the modular seal member 2476 to allow an
instrument to be inserted through the seal housing 2476 into the
body cavity. FIG. 24 also illustrates an embodiment of an access
port 2420 disposed on a mount.
[0110] FIG. 25 illustrates yet another exemplary embodiment of a
surgical access device 2510 that includes a hollow tubular member
2512, a modular seal member 1514, and one or more access ports
2541. In this embodiment, as in FIG. 24, a trocar that includes a
pointed tip 2572, an elongate shaft 2474 and a proximal seal
housing 2576 can be inserted through an access port 2541 in the
modular seal member. In this embodiment, the access ports 2541 can
be flexible, similar to the flexible connectors of FIGS. 23A and
23B, discussed above. The distal seal housing 2576 can be mated to
a flexible access port 2541 using one or more tabs 2470t. The
tab(s) 2470t can engage a complementary slot in the access port
3541 when the seal housing 2576 is rotated, thereby retaining the
seal housing 2576 in the access port. In this embodiment, the
pointed tip 2572 of the trocar 2570 can be configured to puncture
tissue, e.g., fascia, to allow the trocar 2572 to pass into a body
cavity underlying the tissue until the seal housing 2576 makes
contact with and is engaged with the access port 3541. The trocar
2572 can then be removed from the seal housing 2576 to allow an
instrument I to be inserted through the seal housing 2576 into the
body cavity. As shown, a flexible mount 2542 can provide increased
range of motion of an inserted instrument I by allowing the seal
housing 2576 to move relative to the hollow tubular member 2512.
One skilled in the art will appreciate that the various seal
housings and trocars shown in FIGS. 24 and 25 can pass through and
mate with any of the mounts or seal housings disclosed herein.
[0111] In another embodiment, illustrated in FIGS. 26A and 26B, an
access port 2676 can be configured to be inserted through a mount
2641 in a hollow tubular member 2612 of a surgical access device
2610. Such insertion of the access port 2676 can cause deployment
of an anchoring device 2650 within a body cavity to secure the
access port 2676 within the mount 2641. The anchoring device 2650
can be inserted through the mount 2641 in an undeployed
configuration (shown in FIG. 26A) and can dynamically move to a
deployed configuration (shown in FIG. 26B) when the anchor device
2650 moves into the body cavity. A projection 2676 on a shaft 2676s
of the access port 2676 can engage the body of the mount 2641 such
that additional force applied to the access port 2676 can deploy
one or more wings 2650w that can extend away from the body of the
access port 2676 against the hollow tubular member 2612, or fascia,
if present. In another embodiment, the anchor device 2650 can be
deployed manually after the access port 2676 has been inserted
through the mount 2641.
[0112] FIG. 27 illustrates an exemplary embodiment of a surgical
access device 2710 that includes a hollow tubular member 2712, one
or more access ports 2741, and an insufflation port 2750. As shown,
the insufflation port 2750 can be molded into the hollow tubular
member 2712 or a modular seal member (not shown). Any and all of
the surgical access devices described herein can include various
ventilation ports to allow evacuation of smoke during procedures
that utilize cautery, and/or one or more insufflation ports through
which the surgeon can insufflate the abdomen to cause
pneumoperitenium, as described by way of non-limiting example in
U.S. Patent Application No. 2006/0247673 entitled "Multi-port
Laparoscopic Access Device" filed Nov. 2, 2006, which is hereby
incorporated by reference in its entirety. The insufflation port
can be located anywhere on the device, can have any size, and can
accept a leur lock or a needle, as will be appreciated by those
skilled in the art.
[0113] FIGS. 28A to 28C illustrate another embodiment of a surgical
access device 2810 including a hollow tubular member 2812. In this
exemplary embodiment, the hollow tubular 1812 member can include an
anchoring mechanism 2850. The anchoring mechanism 2850 can include
a linkage system 2852 that actuates a retention member 2854. In
this embodiment, a spherical sealing ball 2890 can be mated with
the proximal end 2852p of the hollow tubular member 2812, as shown
in FIGS. 28B and 28C. The spherical sealing ball 2890 can flexible
or rigid, and can be puncturable to permit one or more instruments
I to be inserted therethrough. The spherical sealing ball 2890 can
also be self-sealing. The spherical sealing ball 2890 can be formed
from any material or combination of materials known in the art,
e.g., gels, rubbers, foams, foamed polypropylene polyurethane,
polyethylene, etc. The spherical sealing ball 2890 can be retained
within a flared proximal region 2814 of the hollow tubular member
1812 in any number of ways, e.g., frictionally retained, adhesively
bonded, mechanically retained by a groove, etc. As shown in FIG.
28C, the one or more instruments I can be inserted through the
spherical sealing ball 2890 mated to the hollow tubular member 2812
and into the hollow tubular member 2812 to provide access to a body
cavity.
[0114] FIG. 29 illustrates another embodiment of a surgical access
device 2910 that includes a housing 2920, a retractor 2930, and a
modular access port 2940. The retractor 2930 can extend from the
housing 2920, and it can be configured to be positioned in an
opening formed in tissue. The retractor 29230 can, as shown in this
exemplary embodiment, be a substantially flexible member having a
proximal flange 2931 and a distal flange 2932 with an inner
elongate portion 2934 extending therebetween. The inner elongate
portion 2934 can have a diameter less than a diameter of the
proximal and distal flanges 2931, 2932 which can have the same
diameter or different diameters from one another. A proximal o-ring
can be optionally positioned within the proximal flange 2931 to
help provide structural support to the retractor within the
proximal retractor base. A distal o-ring can optionally be
positioned within the distal flange 2932 to provide structural
support to the retractor within a patient's body. The proximal and
distal o-rings can be substantially flexible or substantially rigid
as needed, same or different from one another, for use in a
particular application. Any engagement and release mechanism known
in the art can be used to releasably mate the housing and the
retractor together, for example, the housing can receive the
retractor 2930 in a recessed groove around the outer circumference
of the housing 2920.
[0115] As shown in FIG. 29, the housing 2920 can include one or
more concentric rings 2922 that can move independently from each
other similar to those discussed above regarding FIG. 22. Each ring
2922 can include one or more openings 2922 configured to receive a
modular access port 2940. The modular access ports can be
configured in any way and can be any shape and size. As shown in
FIGS. 29 and 30A, modular access ports 2940, 2940a can each include
a proximal flange 2942, 2942a and a distal clip 2944, 2944a. The
proximal flange 2942, 2942a can have a diameter greater than the
diameter of the openings in the modular access port 2940, 2940a.
The distal clip 2944, 2944a can have a slot 2946, 2946a formed in a
distal portion thereof so as to allow the distal tip 2948, 2948a of
the clip 2944, 2944a to deform so as to retain the modular access
port 2940, 2940a within an opening. For non-limiting example, the
deformation of the distal tip 2948, 2948a of the clip 2944, 2944a
can provide a frictional engagement with the walls of the opening
2922. For another non-limiting example, the distal tip 2948, 2948a
can mechanically engage a clip feature within the opening (not
shown). One skilled in the art will appreciate that any mechanical
or frictional means known in the art can be employed to retain the
modular access port within an opening. The access ports 2940, 2940a
can also have an opening 2941, 2941a formed therethrough to allow
passage of an instrument. The access ports 2940, 2940a can also
include various sealing elements known in the art, e.g., duckbill
seals, cone seals, flapper valves, gel seals, diaphragm seals, lip
seals, iris seals, etc. as discussed in more detail above. In some
embodiments, a gimbal seal 2950, such as that shown in FIG. 30B,
can be used. A gimbal seal 2950 can include a frame 2952 that
connects a sealing element to a base member. The sealing element
2954 can include a gimbal 2956 and a sealing element 2958 disposed
within the gimbal 2956. The gimbal 2956 can rotate and move in all
directions within the frame 2952 to allow a full range of movement
for a surgical instrument inserted through the sealing element
2958. The sealing element 2958 can form a seal around an instrument
inserted therethrough.
[0116] At any point before, during, or after a surgical procedure,
a modular seal member 3114 of a surgical access device 3110 can be
released from a retractor and/or a hollow tubular member 3112 and
removed from the device 3110, as shown in one embodiment in FIG.
31. With the modular seal member 3114 of the device 3110 disengaged
from the hollow tubular member 3112, the lumen 3118 of the hollow
tubular member 3112 can still provide access to a body cavity
underlying tissue. As shown in one embodiment in FIG. 32, one or
more surgical instruments I can be advanced through a lumen 3218 of
the hollow tubular member 3212 with a modular seal member 3214
removed therefrom and can be used to manipulate or remove tissue
directly through the lumen 3218 of the hollow tubular member 3212.
Any other surgical instrument can be advanced through the lumen
3218, such as a waste removal bag configured to hold waste
material, e.g., dissected tissue, excess fluid, etc., for removal
from the body cavity. A person skilled in the art will appreciate
that one or more surgical instruments can be advanced through the
lumen 3218 before and/or after the modular seal member 3214 has
been attached to the device 3210.
[0117] FIGS. 33A to 33C show another exemplary embodiment of a
surgical access device 3310 that includes a hollow tubular member
3312, a retractor 3360 and a modular seal member 3314. In this
embodiment, the modular seal member 3314 can include a specimen bag
3316 attached directly to an outer ring 3328 configured to mate
with the hollow tubular member 3312, as shown in FIG. 33B. The
outer ring 3328 can be configured in any number of ways. For
non-limiting example, the ring 3328 can include a tab and various
grooves that can engage features on the hollow tubular member 3312
as discussed in more detail above. The specimen bag 3316 can be
also configured in any number of ways and can be made from any
number of materials, such as polyethylene, etc. As in the
illustrated embodiment, the specimen bag 3316 can include a draw
string 3318 that can be sewn or woven into a proximal portion of
the specimen bag 3316.
[0118] In use, the specimen bag 3316 and the outer mounting ring
3328 can be inserted into the hollow tubular member 3312. As shown
in FIG. 33A, a grasper 3390 can be used to maneuver the ring 3328
into position such that it is mated to the hollow tubular member
3312. A grasper 3390, or other instrument, can then be used to
grasp a tissue specimen 3320 through the specimen bag 3316, as
shown in FIG. 33B. Using the instrument 3390, the tissue 3320 can
be withdrawn through the hollow tubular member 3312, inverting the
specimen bag 3316, as shown in FIG. 33C. The specimen bag 3316 can
then be closed, for example by tensioning the draw string 3318 to
reduce a diameter of the opening 3330 in the bag 3316. One skilled
in the art will appreciate that the bag 3316 can be closed by any
number of other methods such as heat sealing, twisting, etc. The
outer ring 3328 can then be released from the hollow tubular member
3312. In some embodiments, the specimen bag 3316 can be cut from
the ring 3328 between the closed opening of the bag 3316 and the
ring 3328 to separate the specimen bag 3316 from the ring 3328.
[0119] The embodiments described herein can be used in any known
and future surgical procedures and methods, as will be appreciated
by those skilled in the art.
[0120] The devices disclosed herein can be designed to be disposed
of after a single use, or they can be designed to be used multiple
times. In either case, however, the device can be reconditioned for
reuse after at least one use. Reconditioning can include any
combination of the steps of disassembly of the device, followed by
cleaning or replacement of particular pieces, and subsequent
reassembly. In particular, the device can be disassembled, and any
number of the particular pieces or parts of the device can be
selectively replaced or removed in any combination. Upon cleaning
and/or replacement of particular parts, the device can be
reassembled for subsequent use either at a reconditioning facility,
or by a surgical team immediately prior to a surgical procedure.
Those skilled in the art will appreciate that reconditioning of a
device can utilize a variety of techniques for disassembly,
cleaning/replacement, and reassembly. Use of such techniques, and
the resulting reconditioned device, are all within the scope of the
present application.
[0121] Preferably, the invention described herein will be processed
before surgery. First, a new or used instrument is obtained and if
necessary cleaned. The instrument can then be sterilized. This can
be done by any number of ways known to those skilled in the art
including beta or gamma radiation, ethylene oxide, steam, and a
liquid bath (e.g., cold soak). In one sterilization technique, the
instrument is placed in a closed and sealed container, such as a
plastic or TYVEK bag. The container and instrument are then placed
in a field of radiation that can penetrate the container, such as
gamma radiation, x-rays, or high-energy electrons. The radiation
kills bacteria on the instrument and in the container. The
sterilized instrument can then be stored in the sterile container.
The sealed container keeps the instrument sterile until it is
opened in the medical facility.
[0122] One skilled in the art will appreciate further features and
advantages of the invention based on the above-described
embodiments. Accordingly, the invention is not to be limited by
what has been particularly shown and described, except as indicated
by the appended claims. All publications and references cited
herein are expressly incorporated herein by reference in their
entirety.
* * * * *